GXR RM China BE Study (Darmstadt - Jiangsu)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Test Glucophage® XR; Drug: Reference Glucophage® XR

• Registration Number: NCT05463094
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Brief Summary

The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Study Start: 2022-07-25
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator.
• Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square).
• Participants with all values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator.
• Other protocol defined inclusion criteria could apply.

Exclusion Criteria

• Participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
• Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction.
• Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion.
• Participation in a clinical study within 90 days prior to first drug administration.
• Non-acceptance of study high-fat breakfast.
• Other protocol defined exclusion criteria could apply .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Reference GXR RM (Fasted), Then Test GXR RM (Fasted)	Test Glucophage® XR	Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Test GXR RM (Fasted), Then Reference GXR RM (Fasted)	Test Glucophage® XR	Participants will receive a single dose of Test Glucophage Extended Release Reduced Mass (GXR RM) tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Reference GXR RM (Fasted), Then Test GXR RM (Fasted)	Reference Glucophage® XR	Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Test GXR RM (Fed), Then Reference GXR RM (Fed)	Reference Glucophage® XR	Participants will receive a single dose of Test GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
First Reference GXR RM (Fed), Then Test GXR RM (Fed)	Reference Glucophage® XR	Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
First Test GXR RM (Fasted), Then Reference GXR RM (Fasted)	Reference Glucophage® XR	Participants will receive a single dose of Test Glucophage Extended Release Reduced Mass (GXR RM) tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Test GXR RM (Fed), Then Reference GXR RM (Fed)	Test Glucophage® XR	Participants will receive a single dose of Test GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
First Reference GXR RM (Fed), Then Test GXR RM (Fed)	Test Glucophage® XR	Participants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Metformin	Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Metformin	Pre-dose up to 48 hours post-dose on Day 1 and Day 8

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Plasma Concentrations of Metformin	Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination	Baseline up to Day 10
Number of Participants with Treatment-Emergent Adverse Events (AEs)	Baseline up to Day 10

Trial Locations

Locations (1)

Research Site; 🇩🇪 Darmstadt, Germany